Patent Application
20210220548
The invention generally relates to medical fluid ports and, more particularly, the invention relates to flushing medical fluid ports.
Many patient fluid transfer applications require a medical practitioner to administer fluid to or take a sample of blood or fluid from the patient through an indwelling catheter. To that end, the practitioner typically uses a fluid transfer set having a sample port that allows the medical practitioner to deliver to or draw a sample of the blood or fluid from the patient's indwelling catheter.
In general terms, medical connectors, such as valving devices, often act as a port that may be repeatedly accessed to non-invasively inject fluid into (or withdraw fluid from) a patient's vasculature. Consequently, a medical connector permits the patient's vasculature to be freely accessed without requiring the patient's skin to be repeatedly pierced by a needle. Alternatively, medical connectors may act as a port for other medical applications, such as for accessing fluid containers (e.g., bags, vials), trachea tubes, enteral lines, breathing apparatuses, surgical sites, etc.
Medical personnel insert a medical instrument into the medical connector to inject fluid into (or withdraw fluid from) a patient who has an appropriately secured medical connector. Once inserted, fluid may be freely injected into or withdrawn from the patient.
One such medical connector/medical fluid delivery system is a “T” type connector that may be utilized within the fluid path. One point of entry to the “T” connector may be a needle free connector, and another point of entry may be an extension set, or short length of tubing, and the remaining port of the “T” would be the exit path or “outlet,” which would lead to the patient (See Figured 1A-1D). Often, the clinician should be able to clear the “T” port of residual fluid (medication, blood, etc.) through a flushing operation. Flushing is not typically a challenge when connecting to a needle free connector and pushing fluid straight through the “T” connector. However, when flushing through the extension set tubing, it is difficult to flush the needle free connector portion of the system, as it is not naturally within the direction of flow. For example, as shown in
In accordance with one embodiment of the present invention, a fluid conduit for use in a medical line may have a housing with a body forming an interior. The housing may have a proximal cavity within the interior, an outlet, and a fluid path (with a fluid path longitudinal axis) within the interior and extending between the cavity and outlet. An entry channel may extend through the body of the housing distal to the cavity and may have a radial longitudinal axis. The entry channel may be offset from the fluid path such that the radial longitudinal axis of the entry channel does not intersect the longitudinal axis of the fluid path. This, in turn, may cause at least a portion of a fluid entering the interior of the housing via the entry channel to initiate a swirl-like motion within the interior of the housing. The housing may also have a contact surface within the fluid path. At least a portion of the contact surface may be located distal to the cavity and may intersect the radial longitudinal axis. The contact surface may direct at least a portion of the fluid entering the interior of the housing via the entry channel proximally into the cavity. The entry channel may be configured at an angle such that fluid entering the interior of the housing is directed proximally towards the cavity. In some embodiments, the fluid conduit may include a tubing set having a tube and a medical connector (e.g., a female luer connector). The tube may have a first end and a second end. The tube may be fluidly connected to the entry channel at the first end and the medical connector may be located at the second end. The medical connector may connect to a medical implement (e.g., for introducing fluid into the tubing set). The tubing set may also have a tubing clamp located on the tube. The clamp may transition between an open mode that allows fluid to flow through the tube and a closed mode that prevents fluid from flowing through the tube.
In other embodiments, the contact surface may be angled. For example, the fluid path may include a conical portion with an inner diameter that decreases towards a distal end. The contact surface may be located on the conical portion. Additionally or alternatively, the fluid conduit may include a ramp located within the fluid path and the contact surface may be located on the ramp. The ramp may extend from an inner wall of the housing and into the flow path or the ramp may be recessed into a wall of the housing such that the ramp does not extend into the fluid path. The ramp may be configured at an angle such that fluid entering the interior of the housing is directed proximally towards the cavity. The ramp may extend approximately 180 degrees around the fluid path. In other embodiments, the fluid connector may have a shelf located within the fluid path and distal to the entry channel and the contact surface may be located on a top surface of the shelf.
In accordance with further embodiments, the fluid conduit may have a stabilization pad extending from a portion of the housing. The stabilization pad may stabilize the fluid conduit on a patient during use. Additionally or alternatively, the conduit may have a valve member located within the housing interior. The valve member may have a septum/proximal portion that closes a proximal opening when the valve member is in a closed mode and a valve wall that extends from the septum to form a valve interior. The housing may have an inlet housing and an outlet housing. The valve member may be located at least partially within the inlet housing, and the entry channel may extend through a wall of the outlet housing. In such embodiments, the offset and the contact surface may cause a portion of the fluid to flow into the valve interior.
In accordance with further embodiments, a method of flushing a fluid conduit includes providing a fluid conduit having a housing with a body forming an interior. The housing may also include a cavity within the interior, an outlet, and a fluid path within the interior and extending between the cavity and outlet. The fluid path may have a fluid path longitudinal axis. The fluid conduit may also have an entry channel and a contact surface. The entry channel may extend through the body of the housing and distal to the cavity. The entry channel may also have a radial longitudinal axis and may be offset from the fluid path such that the radial longitudinal axis of the entry channel does not intersect the longitudinal axis of the fluid path. The contact surface may be within the fluid path and at least a portion of the contact surface may be located distal to the cavity and intersect the radial longitudinal axis.
The method may also include connecting a medical implement to a medical connector on a tubing set connected to the entry channel and introducing a fluid into the fluid conduit via the tubing set and the entry channel. The offset may cause at least a portion of the fluid entering the fluid conduit to initiate a swirl-like motion within the fluid path. The contact surface may direct a portion of the fluid proximally into the cavity. In some embodiments, the entry channel may be configured at an angle such that fluid entering the interior of the housing via the entry channel is directed proximally towards the cavity.
In accordance with other embodiments, the contact surface may be angled. For example, the fluid path may include a conical portion and the contact surface may be located on the conical portion. Additionally or alternatively, the fluid conduit may include a ramp located within the fluid path and the contact surface located on the ramp. The ramp may extend from an inner wall of the housing and into the flow path or the ramp may be recessed into a wall of the housing such that the ramp does not extend into the fluid path. The ramp may be configured at an angle such that fluid entering the interior of the housing is directed proximally towards the cavity.
The fluid connector may include a valve member located within the housing interior. The valve member may have a septum configured to close a proximal opening when the valve member is in a closed mode and a valve wall extending from the septum to form a valve interior. The housing may have an inlet housing and an outlet housing. The valve member may be located at least partially within the inlet housing, and the entry channel may extend through a wall of the outlet housing. The offset and the contact surface may cause a portion of the fluid to flow into the valve interior.
Those skilled in the art should more fully appreciate advantages of various embodiments of the invention from the following “Description of Illustrative Embodiments,” discussed with reference to the drawings summarized immediately below.
In illustrative embodiments, a self-flushing fluid conduit (e.g., a medical fluid connector or a T-connector) for use in a medical line includes a housing with a proximal cavity within the interior. An entry channel extends through the body of the housing distal to the cavity and is offset from a fluid path extending between the cavity and an outlet. Fluid entering the fluid conduit via the entry channel begins to at least partly swirl within the interior of the housing and contacts a contact surface which, in turn, directs at least a portion of the fluid entering the interior of the housing via the entry channel proximally toward the cavity. This improves flushing of the cavity and the interior of a valve member within the conduit (if equipped).
To selectively prevent and allow fluid flow through the tube 210 during use, the tubing set 200 may include a clamp 230 on the tube 210. The clamp 230 may have an open mode that allows fluid flow through the tube 210 and a closed mode that prevents fluid flow through the tube 210, for example, by pinching the tube 210 closed. To that end and as discussed in greater detail below, when the user wishes to flow fluid through the tubing, they may open the clamp 230 (e.g., if it is not already open). Conversely, if the user wishes to prevent fluid flow, the user may close the clamp 230.
As shown in
It should be noted that although much of the discussion herein refers to the proximal port 120 as an inlet, and the distal port 130 as an outlet, the proximal and distal ports 120 and 130 also may be respectively used as outlet and inlet ports. Discussion of these ports in either configuration therefore is for illustrative purposes only. Alternatively, the main housing 110 may have a closed proximal end, instead of a proximal port, that surrounds a portion of the proximal cavity 115 to form the proximal portion of fluid path 160.
As mentioned above, within the interior of the housing 110 (e.g., within the fluid path 160), the connector 100 has an elastomeric valve member 150 that seals the proximal port 120. The valve member 150 may include a proximal portion 152 (e.g., a septum) and a valve wall 156 that extends distally from the proximal portion 152 within the interior of the housing 110 (e.g., within the proximal cavity 115). As shown in
In some embodiments, the proximal portion 152 (e.g., the septum) of the valve member 150 may be flush with or extend slightly above an exterior proximal opening face 125 of the proximal opening 120 of the housing 110. The proximal portion 152 of the valve member 150 and the exterior inlet face 125 thus present a swabbable surface, i.e., it may be easily wiped clean with an alcohol swab, for example, or other swab.
As discussed above, a medical implement may be connected to the proximal opening 120 to allow a user to transfer fluid to and/or from a patient. To that end, the valve member 150 includes a resealable aperture 153 extending through the proximal portion 152. Among other things, the aperture 153 may be a pierced hole or a slit. Alternatively, the proximal portion 152 may be molded with the aperture 153. When the valve member 150 is in a closed mode (i.e., preventing passage of fluid), as shown in
During operation (e.g., when transferring fluid to and/or from the patient via the proximal port 120), the medical practitioner may insert the medical implement into the proximal opening/port 120 of the housing 110. As the medical implement is inserted, the valve member 150, which normally closes the proximal opening 120, moves/deforms distally within the interior of the housing 110. As the valve member 150 continues to move/deform distally into the housing interior, the aperture 153 will open (e.g., when the proximal portion 152 enters the larger inner diameter portion of the inlet housing 114) to create fluid communication between the medical implement and the valve interior 158. Conversely, when the medical implement is withdrawn from the proximal opening 120 (e.g., after fluid transfer is complete), the elastomeric properties of the valve member 150 cause the valve member 150 to begin to move proximally within the interior of the housing and return to its at-rest position with the proximal portion 152 within (and closing) the proximal opening 114.
The outside surface of the proximal port 120 may also have inlet threads 90 for connecting the medical instrument. Alternatively or in addition, the proximal end may have a slip design for accepting instruments that do not have a threaded interconnect. In a similar manner, the distal end of the housing 110 has a skirt 170 containing threads 172 (see
As noted above, the conduit/connector 100 may have an entry channel 140 extending through the housing 100 and to which the tubing set 200 may be fluidly connected. As best shown in
As noted above, various embodiments of the present invention are “self-flushing,” meaning that as fluid enters the housing 110 via the entry channel 140, it sufficiently flushes the interior of the housing 110 and valve interior 158 and/or proximal cavity 115 (e.g., the dead space within the prior art T-connector). To that end and as best shown in
The offset between the entry channel 140 and the fluid path 160 causes the fluid entering the housing 110 via the tubing set 200 to enter on one side of the valve interior and begin a “swirl” type motion within the interior of the housing 110 (e.g., within the fluid path 160) (see
It is important to note that the amount of the offset may vary depending on the application and the amount flushing required. For example, in some embodiments, the entry channel 140 (and the tube 210 of the tubing set 200) may offset from the fluid path 160 such that the outer diameter of the entry channel 140 is tangent (or nearly tangent) to the diameter of the fluid path 160. In such a configuration, the diameter of the entry channel 140 is preferably less than the diameter of the fluid path 140. In illustrative embodiments, this relationship may range from 1:2 to 1:4 (entry channel 140 entry diameter to fluid path 160 diameter). Alternatively, as shown in
In addition to the offset entry channel 140, some embodiments may have additional features (e.g., flow directing features) that help direct the fluid entering the housing 110 via the entry channel 140 into the valve interior 158 and/or proximal cavity 115 to increase flushing. For example, the outlet housing 112 may include a conical or frusto-conical portion 180 portion with an inner diameter that decreases towards the distal end (e.g., towards the distal port/outlet 130) (
In addition to or instead of the conical portion 180, some embodiments may have a ramp 190 located within the flow path 160. The ramp 190 may extend around a portion (e.g., 180 degrees) of the inner diameter of the outlet housing 112 (e.g., in the fluid path 160) and extend proximally toward the proximal cavity 115 and valve interior 158 to create an angled surface 192 upon which the fluid entering the housing 110 impinges. To that end, in a manner similar to that described above for the conical portion 180, the fluid entering the housing 110 via the entry channel/tubing set fluid channel 140 will contact the angled surface 192 and flow proximally up the ramp 190 (see
It should be noted that, although
It should also be noted that other flow directing features may be used in addition to or instead of the conical portion 180 and ramp 190 discussed above. For example, some embodiments may include a shelf (not shown) that extends into the flow path 160 distal to the entry channel 140. The top surface of the shelf may act as the contact surface and essentially create a flow restriction that deters the fluid from flowing distally towards the outlet 130 and help to redirect the fluid proximally toward the proximal cavity 115 and/or valve interior 158.
In order to minimize flow disruption and restriction between the inlet 120 and outlet 130, it is preferable that each of the flow directing structures above protrude minimally from the fluid path diameter. This allows the main flow path 160 of the “T” to be open (straight through the main lumen), but also maintaining the ability to direct flow toward the valve interior 158 and/or proximal cavity 115. Alternatively, as noted above for the ramp 190, the flow directing feature may be formed by a recessed geometry within the wall of the main lumen.
It should be understood that the various embodiments of the device 100 described above provide numerous advantages over prior art devices. Among others, under expected fluid flow rates, the design urges more fluid proximally to more fully flush the interior of the valve interior 158 and/or proximal cavity 115. For example,
The embodiments of the invention described above are intended to be merely exemplary; numerous variations and modifications will be apparent to those skilled in the art.
Such variations and modifications are intended to be within the scope of the present invention.
This patent application claims priority from U.S. provisional patent application No. 62/684,499, filed Jun. 13, 2018 entitled, “SELF-FLUSHING PORTS,” assigned attorney docket number 130974-04801 (formerly 1600/A48), and naming Ian Kimball as inventor, the disclosure of which is incorporated herein, in its entirety, by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2019/036743 | 6/12/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62684499 | Jun 2018 | US |
